BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113233·VITRECTOMY KNIFE 19GA (BX/5)

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113240·VITRECTOMY KNIFE 23GA (BX/5)

    INQWIRE DIAGNOSTIC GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Michler-Kapp Cardiovascular Vent Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·November 23, 2022

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·October 27, 2014

    TABS PROFESSIONAL

    FDA Adverse Event
    Death ·STANLEY SECURITY SOLUTIONS, INC.·Product code KMI·June 28, 2013

    HIRES 90K

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC·Product code MCM·August 2, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 13, 2022

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 11, 2022

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 11, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025